Fentanyl composition for nasal administration

Abstract

The treatment of acute pain with a sufficient dosage by intranasal administration of fentanyl results in a time to onset of action comparable to intravenous administration and a significantly faster onset of action than nasal titration of fentanyl. The nasal administration of a sufficient amount of fentanyl to obtain pain relief has lower maximum plasma concentrations comparable to intravenous administration and results in lower rates of adverse events like respiratory depression, nausea and vomiting. Compositions fur use in the method are also disclosed.

1. A device in combination with a liquid pharmaceutical composition comprising a fentanyl salt in a solvent comprising about 95-100% water at a concentration range equivalent to 0.5-20 mg/ml of fentanyl, said device comprising means for intranasal spray delivery of said composition in a dosage unit equivalent to 70 to 500 μg of fentanyl. 
     
     
       2. The device according to  claim 1 , wherein the concentration range is equivalent to 0.6-15 mg/ml fentanyl. 
     
     
       3. The device according to  claim 1 , wherein the concentration range is equivalent to 0.75-10 mg/ml fentanyl. 
     
     
       4. The device according to  claim 1 , wherein the concentration is equivalent to 1 mg/ml. 
     
     
       5. The device according to  claim 1 , wherein the concentration is equivalent to 2 mg/ml. 
     
     
       6. The device according to  claim 1 , wherein said fentanyl salt is fentanyl citrate. 
     
     
       7. The device according to  claim 2 , wherein said fentanyl salt is fentanyl citrate. 
     
     
       8. The device according to  claim 3 , wherein said fentanyl salt is fentanyl citrate. 
     
     
       9. The device according to  claim 4 , wherein said fentanyl salt is fentanyl citrate. 
     
     
       10. The device according to  claim 5 , wherein said fentanyl salt is fentanyl citrate. 
     
     
       11. The device according to  claim 1 , wherein the solvent is isotonic saline. 
     
     
       12. The device according to  claim 1 , wherein the solvent further comprises polyethylene glycol.